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510(k) K850014

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE by Medi-Dent American, Inc. — Product Code EBH

K850014 is an FDA 510(k) premarket notification submitted by Medi-Dent American, Inc. for the device "HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
January 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression Tray, Resin
Device Class
Class I
Regulation Number
872.3670
Review Panel
DE
Submission Type

Other clearances for product code EBH

  • K933745 — PERMAGEN UNIVERSAL BONDING RESIN (January 26, 1994)
  • K930487 — PALATRAY LC MINT (June 18, 1993)
  • K923979 — LC TRAY MATERIAL (November 17, 1992)
  • K923549 — PALADISC LC (September 29, 1992)
  • K912820 — POLYESTER RESIN HAND MOLDED TRAY (August 21, 1991)
  • K905058 — PALAVIT L (June 6, 1991)
  • K902350 — PALATRAY LC RESIN IMPRESSION TRAY MATERIAL (July 26, 1990)
  • K901782 — CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM (June 29, 1990)
  • K890712 — ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS (April 25, 1989)
  • K881838 — MODIFIED PERMAGUM ADHESIVE (July 27, 1988)

FDA data resources